Hollywood

The Botoxed and the Boldfaced

Much of Hollywood is in thrall to Botox’s wrinkle-banishing magic, and others get injected for headaches. But Irena Medavoy, wife of a powerful producer, is suing Dr. Arnold Klein—dermatologist to stars including Michael Jackson and Elizabeth Taylor—along with Allergan, the pharmaceutical giant, for what Medavoy claims was a disastrous overdose. The author reports on a case that could bring frown lines back.

The dermatological hot zone in Los Angeles is on Roxbury Drive in Beverly Hills, specifically at 435 North Roxbury, the medical building that houses so many of the city’s biggest dermatologists and plastic surgeons—or “derms” and “plastics,” as the natives say. Four thirty-five North Roxbury is where Hollywood goes to dye. Or peel. Or nip. Or tuck. Or bleach or flatten or shrink.

Oftentimes, Hollywood goes to the second floor of 435, to the bustling corner office of Dr. Arnold Klein, although practically no one ever calls him that. To his friends he’s just plain “Arnie,” the menschy power derm; to his colleagues, and to the so-called beauty press, he’s the King of Collagen or the Botox King—that is, when he’s not known as the doctor who employed Debbie Rowe, who bore two children, Prince Michael and Paris, to Michael Jackson, whose own epic dermatological journey owes at least something to Arnie Klein. As a character said in the 1990 movie based on Carrie Fisher’s book Postcards from the Edge, “Klein—he does all of them.”

For decades Klein’s clients included a striking, vigorous woman named Irena Medavoy, although she didn’t always go by that name. Medavoy, 44, is the surname of her current husband, Mike, who happens to be one of the more powerful, well-connected men in Hollywood, having run three movie studios during the past quarter-century. Like so many women in Los Angeles, not to mention an increasing number of men, Irena attempted to turn back the creeping tide of age, and her mode of time travel came courtesy of Botox, the miraculous injectable drug that reduces or eliminates even the hardiest wrinkles, albeit temporarily.

That’s not all it does, doctors have lately been discovering. Botox also seems to remedy another unfortunate by-product of Hollywood living, the killer headache, thereby offering double-truck relief to Irena, who for several years had suffered from migraines. But, she says, she got far more than she had bargained for at the hands of Dr. Klein, thus setting the stage for the most extraordinary civil litigation in recent memory, in which one of the most prominent Hollywood wives has charged the town’s most prominent dermatologist with, in essence, reckless Botoxing. It has become an increasingly bitter melodrama, one that would be damn near hilarious were it not for the fact that, after her last treatment by Arnie Klein, Irena Medavoy suffered months of excruciatingly debilitating pain, she says.

Whether Botox and Klein are in any way culpable for Medavoy’s suffering remains an open question, and Klein’s spokesman in this matter, the famed Hollywood attorney Howard Weitzman, sharply disputes Medavoy’s claim, if not her initial symptoms. “I don’t question her motives,” Weitzman says shortly before doing just that. “Motive in the filing of civil suits is generally money. Financial reward or gain. So I think her motive is pretty clear.” That opinion is shared by an even bigger fish in this tank, Allergan, Inc., the billion-dollar pharmaceutical giant that makes and markets Botox. The company calls Medavoy’s suit “frivolous” and a “tactic for financial gain.”

Naturally, this assessment doesn’t sit so well with Medavoy. “I feel like Jane Fonda in The China Syndrome,” she often says these days. “This is my Three Mile Island. I’m telling the truth. It happened to me. But they want to destroy me. This lawsuit is about holding Allergan and Klein accountable for their failure to disclose the risks involved with Botox for migraines. They put profits before people. And if I don’t sue, they’ll keep doing what they’re doing. And it’s not right. They used me as a guinea pig. Without my knowledge or consent.”

Because everyone in Hollywood is friends (as the Medavoys, Klein, and the Weitzmans once were) or ex-friends (as the Medavoys and the other three now are), the mutual j’accuse has created a rift in Beverly Hills, which has divided more or less equally between the Arnie camp and the Irena camp, with both sides digging in for trench warfare. Some of the Medavoys’ friends no longer go to Arnie; some of Arnie’s cast suspicious eyes on Irena, watching her every step along Rodeo Drive for signs that she’s healthier than she says she is. Beyond seating arrangements at the Grill, however, the case involves an even bigger issue, with potentially staggering legal, medical, and financial implications—not only for Irena and Klein, but for the entire Botox-industrial complex. Last year alone the drug earned Allergan $440 million, with sales swiftly increasing this year, thanks to deft marketing, hungry consumers, and doctors who view the drug as a gloriously benign cash cow—more so now that it has carved out a niche in the booming headache-treatment market.

It is, at the very least, compelling that many of the doctors treating headaches with Botox are neither neurologists nor internists; many are dermatologists, like Klein, and plastic surgeons, some of whom have been known to administer the drug in beauty salons and at “Botox parties.” Already hotly debated in medical circles, runaway Botox-mania has pitted derm against derm on the mean streets of Beverly Hills. The last word about its side effects has yet to reveal itself, which is why William Goldman’s saying about Hollywood also applies to the potential risk factors of Botox: Nobody knows anything.

Like many discoveries, Botox’s was accidental. Back in the 1820s a swashbuckling German doctor named Justinus Kerner began dabbling with botulinum, the insidious bacillus of botulism that for centuries had killed poor souls who ate food contaminated with it. Death by botulism is, by any standard, a particularly ghastly way to go, being marginally preferable to death by Ebola only because it kills you even faster. Your muscles deaden, you lose control of bodily fluids, and you feel as if a bomb has exploded your entrails. Your lungs fail, you can’t breathe, and you die. Although an antitoxin now exists, the last fatal domestic outbreak, in 2001, killed a Louisiana woman who ate home-canned food—the most common source of botulism.

Kerner endeavored to make botulism our friend by harnessing the bacterium’s muscle-weakening qualities for therapeutic use. His work laid the foundation for the discovery that the toxin could be used to relieve muscle spasms—specifically, by blocking the release of acetylcholine, a neurotransmitter that tells muscles when to contract. Over the decades, doctors came to use it to treat ocular problems as well, and by the early 1980s research by a San Francisco doctor named Alan Scott had attracted the attention of an ambitious married couple who lived in Vancouver, Alastair and Jean Carruthers, the former a dermatologist, the latter an ophthalmologist.

Having transported a vial of toxin across the Canadian border, Jean began injecting her patients, mainly for muscular disorders of the eye, and the results were as swift as they were successful. One day a patient asked Carruthers, “Why aren’t you injecting the frown area between my eyebrows?”

“Because you’re not spasming there,” she replied.

“But when you inject there, I get this lovely, unworried, untroubled look, and my family really likes it because I don’t walk around looking grim.”

That night over dinner, Jean revealed her patient’s observation to Alastair, who promptly ignored it. The next day, undaunted, Jean injected their assistant’s face with a small dose of botulinum. For weeks, despite ringing phones and cranky patients, the assistant looked as serene as the day is long, and one of the many delicious tidbits to be gleaned from the Botox saga is that Patient Zero was a Canadian office worker named Cathy Bickerton. Still, Alastair blithely notes, “it took us a while to convince people to allow us to inject deadly poison into them to get rid of wrinkles.” Nevertheless, by 1993 he was addressing the American Academy of Dermatology, a gathering that effectively served as the toxin’s coming-out ball—an epochal moment marred only slightly by the loud chorus of skeptics crying, as Alastair recalls it, “No bloody way”

By then the toxin had assumed a commercial and far less creepy name—Botox. In 1989 the U.S. Food and Drug Administration had approved it for treatment of crossed eyes and uncontrollable blinking, and in 2000 for a neurological movement disorder known as cervical dystonia. In 2002 it was approved for a single cosmetic procedure: reduction of glabellar lines—a fancy way of saying the “frown lines” that appear between or just above the eyebrows. Needless to say, the cosmetic procedure got all the press and generated most of the cash, which soon started coming in hand over fist, especially in and around Beverly Hills, where wrinkles and death are pretty much synonymous, and where “anal bleaching” is not unheard of.

Into the Botox windfall stepped most of Hollywood’s top derms, among them Arnie Klein, the marketing whiz who’d been one of the architects of the collagen-mania that swept Hollywood in the mid-90s, when actresses suddenly pouted with lips the size of Michelins, thanks to injections of the gelatinous protein. When Goldie Hawn parodied the trend, in 1996’s The First Wives Club, she had Arnie Klein written all over her face—literally: the film’s producers flew Dr. Klein to New York and put him up in the Sherry-Netherland, where he regularly inflated Goldie. He was in on the joke, up to a point. “Here in Los Angeles, we’ve all seen Peter Pan a few too many times,” Klein later said. “[But] if we had movie houses filled with actors and actresses who were ugly, no one would go.”

Spoken like a true native, although Klein isn’t one. He’s from Mount Clemens, a blue-collar exurb of Detroit, where his family ran a spa famous for its mineral baths. Hardworking and precocious, Klein attended college and medical school at the University of Pennsylvania and completed an internship and residency at Cedars-Sinai and U.C.L.A., respectively. That was when he decided the future lay in Los Angeles, “where, I quickly realized, they really need dermatologists,” he said during a brief phone interview with V.F. Before long, Klein was a king among kings, dermatologically speaking, with such patients as Michael Jackson, Elizabeth Taylor, Nancy Davis, Carrie Fisher, and director Penny Marshall.

Along the way, and notwithstanding his shaggy, bearded appearance, Klein didn’t become simply Hollywood’s biggest dermatologist; he became its first celebrity dermatologist, a boldfaced name in his own right, turning up on society pages and at the sort of fund-raisers Hollywood types inevitably describe as “galas,” several of which he sponsored. Klein’s C.V. is chockablock with prestigious affiliations, from his directorships at the American Foundation for aids Research and the Hereditary Disease Foundation to his associations with numerous medical journals to his work with U.C.L.A.’s Fund for Treatment of Women with Breast Cancer—which, by the way, he co-founded. According to Los Angeles magazine, he has two spectacular houses in the area—a mansion in Hancock Park and an oceanfront place in Laguna Beach. Both feature white walls covered with Lichtensteins, Hockneys, and Ruschas, not to mention photos of Klein’s famous friends and patients.

This being Los Angeles, celebrity patients are good for business, even when logic suggests they shouldn’t be—Michael Jackson, for instance. It’s unclear what Klein did or didn’t do to the pop star’s ever changing visage, but he definitely did something, evidently on the judicious side. In 1993, according to an affidavit police filed during their child-molestation investigation of Jackson, the star told Klein that he’d burned his own genitals with Benoquin, a bleaching product. “Dr. Klein told Jackson not to put Benoquin on his genitals,” the affidavit duly reported. Three years later, in 1996, Jackson wed one of Klein’s assistants, the fertile Debbie Rowe, who may or may not have helped business when the New York Post published a photo of her in Klein’s office, topless.

In March, when Harpers and Queen magazine named Klein Hollywood’s top Botoxer, it was old news. “Klein is very big,” says another prolific Hollywood Botoxer, Dr. Paul Nassif. “Klein’s huge.” He helped the F.D.A. determine the appropriate spots for Botox injection, and by last year he’d collagened or Botoxed more than 90,000 patients. “He has a ton of experience with Botox,” says Jeff Roth, one of New York’s most respected dermatologists. “He’s widely considered to be a national expert on Botox. He’s very well known, and he’s actually a nice guy, too.”

That’s what most of Arnie Klein’s patients say about him as well. “He’s the most brilliant doctor in the world,” Elizabeth Taylor announced at a recent aids benefit co-sponsored by Klein. “He has helped save my life. He’s supposed to be a dermatologist, but he’s so much more. I cannot tell you how many times he has seen me and said, ‘Elizabeth Off to the hospital’”

Then again, Irena Medavoy used to praise Dr. Klein just as enthusiastically.

‘I‘ve never been sued and I’ve never sued,” Irena says, sitting in the living room of her family’s plush Beverly Hills estate, and here it should be mentioned that the Medavoys and the advertising staff of V.F. recently co-hosted a Golden Globes party at that address. [Editor’s note: The impetus for this story in no way stemmed from the Medavoys, and no one who worked on this article, including the magazine’s editor, attended the event.] She’s wearing a simple sweater and pants, her hair is pulled back, and her crystal-blue eyes seem weary, rheumy even. “Arnie Klein was somebody I trusted, and somebody who was my friend. And when this happened, he didn’t take care of me.” She stops, fighting back tears, and re-arranges a plate of berries laid out by her assistant. “Klein conducted himself, at all times, above and beyond what was required of him by the medical community,” says Howard Weitzman, a partner at the Proskauer Rose law firm and a celebrity in his own right, having represented John DeLorean, Ozzy Osbourne, and O. J. Simpson.

Although she passes for a California blonde and grew up in Los Angeles, Meda- voy’s Russian bone structure suggests her maiden name, Gerasimenko. Her mother was a nurse at U.C.L.A., her father an architect for Disney who worked on rides such as the Country Bear Party, among other attractions. Sociable and outgoing, Irena attended Hollywood High (with future actress Rita Wilson), working after school as a flunky at The Hollywood Reporter. She was always a looker, always robust, her worst ailments being the occasional headache and a little acne. As with any teenage girl in Hollywood, even the mildest pimples demanded prompt attention, and who better to give it than Arnie Klein? He treated her for years, during which time she became a successful model, featured in ads for Diet Pepsi and Sanyo, even showing up in *Sports Illustrated’*s 1980 Swimsuit Issue. She briefly dabbled in acting, appearing on Dallas and the sitcom Night Court, and with Ted Danson in a TV movie.

By the time Irena met Mike Medavoy, in 1993, they both were multiply divorced (not counting an annulment on Irena’s side). Mike’s exes included the litigious Patricia Duff; Irena’s, former Fox Television chairman Harris Katleman and a fellow named Brock Ward, brother of actress Sela Ward. Mike and Irena married on Bastille Day 1995, in Saint-Tropez, and soon became one of Hollywood’s most visible power couples, forever hosting fund-raisers for Democratic candidates, for a charity called Coach for Kids, and, in the wake of 9/11, for an industry task force for emergency preparedness. The airy foyer of their house is filled with photos of the Medavoys and Barbra Streisand, the Medavoys and Bill Clinton, the Medavoys and Larry King.

There isn’t a photo of the Medavoys with Arnie Klein, though such photos may exist—somewhere. The three mixed easily, and Irena had rejoined Klein’s cosmetic brigade, receiving occasional collagen shots and quarterly Botox injections—the standard Hollywood regimen for wrinkle management. Botox works for three to six months, depending on dosage and physiology; it’s administered by units, each equaling precisely the dose it takes to kill a mouse. A typical cosmetic treatment is 20 units per “site.” Although treating glabellar lines constitutes the only cosmetic use indicated by the F.D.A. and Allergan, doctors routinely inject other facial areas—crow’s-feet around the eyes, laugh lines, and creases near the nose. Known as “off-label use,” practices such as these have anecdotally proved as useful as they are gray. Because the F.D.A. requires rigorous clinical proof before approving a drug, one of the ways doctors gather evidence is through off-label use. That’s how aspirin came to be used as a preventive for heart disease.

Over the course of three visits in 2001, Klein injected Medavoy with 63 units, 73 units, and then 65 units of Botox—higher than average doses, but not outrageously so. Aside from fleeting tenderness around her injection sites and brief flu-like symptoms, she experienced no side effects—which is typical of Botox patients, who rarely complain. (Usually, the mild injection pricks are as bad as it gets.) Medavoy says the trouble didn’t begin until her last visit, on March 4, 2002—when, for at least the second time, Klein used Botox also to treat the migraines that had periodically bedeviled her over the past several years. Every month or so, a migraine could leave her bedridden for a day but lift by the next morning, thanks to Imitrex, a migraine-relief drug, prescribed by her neurologist.

It’s starting here that accounts differ, sometimes wildly. According to Medavoy, Klein had asked, unbidden, if she had ever experienced headaches, and then summoned an assistant, who volunteered that Botox had reduced her migraines by 50 percent. Medavoy agreed to try the treatment, she says, and Klein began Botoxing her not just in the usual facial regions but in the back of her neck at the base of her skull and behind each ear. During the last visit, “I was leaning down there for a long time,” she says, pantomiming being injected from behind. “Long enough for me to say, ‘Arnie, it’s too much.’” Weitzman says this “never happened, and [if it had] how would Irena have known [it was too much] unless she had an immediate reaction, which she didn’t, according to her own statements.”

The next day, Medavoy and her neighbor Jennifer Stallone took their children to Disneyland—Irena has a son, Nicholas, who was four at the time—where they rode the “teacups.” As the week wore on, Medavoy says, she began to experience flu-like symptoms. By the end of the next week, she was in the emergency room at U.C.L.A., debilitated by crushing headaches, fever, blurred vision, ringing ears, respiratory problems, gastric distress, and difficulty in swallowing, known as dysphagia. When she had reported her symptoms to Klein, she says, he replied, “Oh I did too much Botox. I shouldn’t have done the cosmetic and the migraine. But don’t worry. The pain will only last two to four days.” Weitzman flatly denies that Klein made this statement.

Initially, Medavoy says, emergency-room doctors suspected pneumonia, then were flummoxed. “My head,” she says, sighing. “It was like my neck could not support my head. Where he shot—where the injection shots were—I’m telling you, I’d never been so sick in my whole life, and I knew something was wrong. And I knew it was the Botox because the pain was in that area. I thought my head was gonna go … ” She pantomimes her head exploding.

Later, Medavoy says, “I missed a Coach for Kids fund-raiser and a show I was taping with [actress] Cynthia Sikes Yorkin and Jennifer Stallone and Vanna White. I missed the Vanity Fair Oscar party, missed going to the Oscars. That Monday we were supposed to go to Maui—which I was so looking forward to—with [founder of People for the American Way] Norman and Lyn Lear for a two-week vacation. I missed that. I missed our anniversary trip. We were going to spend the month of June in Europe, going to Paris and then on a boat in the South of France. I missed that. People had invited me to Aspen for August. I missed that.”

Days after her Botoxing, Medavoy says, one of Klein’s assistants left a message on her answering machine, relaying instructions from Klein to see a neurologist. That same week, Medavoy was driven to Dr. Andrew Charles, the neurologist who’d been treating her migraines. Klein hadn’t consulted with Charles, who didn’t like what he saw. “Why would you do this?” Charles asked Medavoy, incredulous. “Why would you take Botox for migraines?” Weitzman says that his client’s conduct was “perfectly appropriate, given the circumstances. He’s treated many others for migraines, with great success.”

What Charles saw in Medavoy, he says, was an “intractable, medication-unresponsive, daily, incapacitating headache that, in my view, was quite clearly related to the Botox. Because it was in the right time frame,” i.e., only a few days after the injections. In the past, Medavoy’s migraines, which Charles classifies as “garden variety,” had always responded to medication. But not this one. “She was diffusely tender in the region where she was injected,” Charles says. “She was in miserable shape.”

The misery didn’t cease—not for days, not for weeks. Medavoy says she was bedridden, unable to handle light, unable to do just about anything. She disappeared from sight, rarely returning calls. She spent nights sobbing in the arms of her husband, who assured her that she wasn’t going insane. “Watching my wife suffer through this period was not fun,” says Mike, who ran Orion Pictures and TriStar Pictures before co-founding Phoenix Pictures, whose titles include The People vs. Larry Flynt and The Thin Red Line. “My wife and I lost a year of our lives. She’s the love of my life, and this should not go without some notice to people that there are risks.”

Klein stopped returning her calls, Irena says, brandishing a phone log to back up her claim. After several weeks, Klein finally called back, she says, with a representative from Allergan, located just down the 405 freeway, in Irvine, on another extension. The Allergan person insisted that her symptoms would abate in “two months.” Five minutes later, she says, Klein phoned back alone, postulating that her trip to Disneyland had made the Botox “go systemic”—another statement Klein denies making. That conversation, she says, was their last.

Two months became four months, with no relief. “I’ve never seen anyone look so sick,” says Jennifer Stallone, who has vacationed with Irena and their husbands, Sylvester and Mike. “She wouldn’t even let me open the shades.” This account is supported by three other friends, including Red Barris, ex-wife of Chuck Barris, the Gong Show host and self-styled C.I.A. assassin. “For 12 years, I spoke to her every day,” says Donna Estes Antebi, who befriended Irena in 1990, on Anguilla, and later introduced her to Mike. “Absolute night and day,” she says of Irena’s sudden decline. “When this happened—once she got into bed—I spoke to her less than three minutes in three months. When I finally got to see her … I couldn’t have been more shocked. I thought she was going to die. She had lost 18 pounds, was white and shaky. She could hardly stand. She could hardly speak.… She was so skinny and so frail.”

Irena saw doctor after doctor. Her inter-nist, Robert Huizenga, who once testified on behalf of O. J. Simpson, concurred with her neurologist. “Before this whole thing happened, she was at the top of her game,” Huizenga says. “She went from being very active and extremely functional to somebody who was essentially bedridden, who basically couldn’t get out for more than 15 minutes.… This was a major catastrophe.” He adds, “We went into this tight circle of trying to make sure it wasn’t anything else. It wasn’t cancer. It wasn’t multiple sclerosis or some kind of neuro-disaster. It wasn’t some kind of psychiatric breakdown. It wasn’t some kind of weird infection. When all those tests turned up negative—and when somebody deteriorates very rapidly and very severely [after a medical procedure]—we were back to that. And most of the other experts here were thinking along those same lines.”

Here being U.C.L.A., the renowned teaching hospital where Arnie Klein happens to be a professor, and where two of his respected colleagues—Charles and Huizenga—blame Botox for Medavoy’s suffering. For starters, Huizenga questions Klein’s claim that Medavoy received 86 units of Botox that day. By his estimate, she received upwards of 110, but he doesn’t know for sure. Plus, Charles says, referring to the drug’s three-to-six-month window, “It happened within the right time frame, [and her most acute pain] lasted two or three months. She hit bottom at two months, and then she started to gradually improve.” Early on, Charles says, he called Klein. “This is where things get a little sticky, because he’s on the clinical faculty here.… I’m not in a good position to comment specifically about his involvement. But I can tell you that I would have liked to have been consulted prior to her receiving injections for headache, and that my conversations with him after the procedure were not particularly helpful.”

‘She couldn’t do anything in the way of exercise at all,” says Medavoy’s physical therapist, who works with many Hollywood clients. “It would exhaust her immediately until around June”—at least three months after the Botox. “It was horrific. She looked like death warmed over. Her signs and symptoms were impossible to fake,” the physical therapist adds. “At the base of her skull, and behind the ears and at her temples, they would be warm to the touch. Clammy at times. I could feel tightness, [and the injection sites] felt inflamed and irritated.”

Glacially, after three to four months, Medavoy turned a corner, doing pool therapy, sharing quick meals with friends, picking her spots to socialize. “The first time I saw her was after three or four months,” Jennifer Stallone says. “She came down, we chatted for a few minutes, then she went upstairs to bed. That wasn’t the Irena I knew, believe me. It took months before she could do the simplest things, like shopping. And she still isn’t anywhere near what she once was.”

“Good days and bad days,” Medavoy says today, nearly a year since her last Botox. “By October, I was able to go to a black-tie event.” Fiddling with the plate of berries, she stares out the window and wonders aloud, “Why didn’t Arnie Klein take care of me? He works seven minutes from here. Never in a million years would I have sued if Allergan and Arnie Klein had come over immediately and said, ‘We want to help you. We want to learn from you.’ Not a chance. But now, knowing the information I’ve found out, it’s what they do. They try to make you go away.”

“Her description of events is inconsistent with what I know about Dr. Klein’s conduct,” says Howard Weitzman. “His general mode of conduct is exceptionally responsive to patients. I’m not certain at what stage he and Irena communicated less. My recollection is that she stopped communicating with him, rather than the opposite. Because she started to blame him.”

Medavoy’s lawsuit, which seeks unspecified damages, alleges that Klein committed malpractice by failing to get “informed consent” for Botox and its potential side effects, especially those stemming from off-label treatments such as hers. Although she signed a medical waiver provided by Klein, the waiver made no mention of serious side effects. She’s also suing Allergan for product liability, calling Botox “an inherently dangerous product requiring proper directions and warnings to independent physicians and/or to patients.” She says, “If Arnie had said, ‘On a couple of occasions, there have been adverse reactions,’ or had given me a research paper that said ‘life-altering headaches,’ I would have said, ‘Let me think about this.’”

That she uses the term “life-altering headaches” is not accidental; it comes from an article published in the January 2002 issue of the Journal of the American Academy of Dermatology, one of the specialty’s most influential publications. Aptly titled “Severe, Intractable Headache After Injection with Botulism A Exotoxin,” the article cited four such cases, which together composed 1 percent of all the patients studied. This article forms the centerpiece of Medavoy’s legal case, indicating that Botox isn’t completely safe and therefore shouldn’t have been administered without informed consent. After she fell ill, Medavoy says, Klein did acknowledge the four cases—a claim disputed by Weitzman.

If in fact Klein did know about these incidents, why didn’t he inform Medavoy about them, pre-Botox? According to other patients who’ve been injected by Klein, he’s never mentioned serious side effects to them, and when recently asked, “May I please have whatever I need to know before Botox?,” a member of his staff handed over a glossy brochure that says, “Discomfort is minimal and brief.” But closer examination of Allergan’s own literature—widely available but not always given to patients by doctors—reveals “rare spontaneous reports of death … and/or other significant debility,” as well as rare instances of “muscle weakness” that, while usually brief, “may last several months.” Also, there have “been rare reports of adverse events involving the cardiovascular system … some with fatal outcomes.”

Most of these indications were published in their promotional materials only after Allergan received a scorching letter from the F.D.A. in August 2001, some seven months prior to Medavoy’s last treatment. “You minimize the side effects,” the F.D.A. complained. “You fail to present all of the serious and important risks associated with Botox … omitting that adverse events may have a duration of several months and may be severe in intensity.”

And yet many experts, including the doctors who published the aforementioned article, believe the toxin is a safe and effective treatment for a range of maladies, from rectal fissures to multiple sclerosis to migraines, especially. By some estimates, it would take roughly 3,500 units of Botox to kill a human. “It’s not kryptonite,” says Jeff Roth, the New York dermatologist, who also has a Ph.D. in molecular biology. “We’re not injecting botulism, first of all. We’re injecting a product of the botulism bacterium, in just the way that penicillin is a product of a mold. Most antibiotics are natural products of other micro-organisms, and Botox is qualitatively no different.” Once injected, practitioners contend, the toxin “spreads” by no more than a quarter-inch. Even if it were accidentally injected into an artery, they say, the effect would be minimal—a fraction of what it takes to make a person seriously ill. “The key with Botox is that it’s transient,” says Dr. Andrew Blumenfeld, a headache specialist and Allergan consultant. “The medicine works from three to six months. By six months, your functionality returns to your baseline level. There is no permanent change.”

Because reports of “intractable” headaches are few and anecdotal, goes the collective reasoning, they’re clinically insignificant. Also, they may indicate that the procedure, rather than Botox itself, is the problem. “The medicine is only as good as it is injected,” Blumenfeld says. “You can’t produce an allergic reaction by injecting it incorrectly, but you could produce abnormal muscle weakness that might make headaches worse—if you don’t do it the right way. I would argue that the technique is at fault when we inject for headache. If you inject all the way down to the bone, you can traumatize it, and that could produce a headache. No doubt about it.”

Klein’s technique is among the many issues Medavoy and her attorney Art Leeds are raising, citing the three injections in the back of her neck. In 2001, they point out, the F.D.A. warned Allergan that “injections into the levator scapulae”—a back muscle that runs up the side of the neck—“may be associated with an increased risk of upper respiratory infection and dysphagia.” Also, they dispute claims that Botox can’t spread through a patient’s body, as they suspect it did in Medavoy’s, and here one need look no further than Allergan’s literature, which notes that studies “may indicate spread of the toxin via circulation” or “some action of the toxin at a third, central, or unidentified site.” “There’s no way it stays in that spot only,” biochemist Nicholas Abrishamian was quoted as saying last year in The Lancet, a prominent British medical journal. “It works by causing damage to the nervous system.… They say ‘minute’ quantities are given for cosmetic purposes, which is true. But quantity is not the only issue when it comes to toxins.”

Allergan isn’t saying much, aside from its assertion that “the persistent conditions which Mrs. Medavoy is claiming are completely inconsistent with our 20-year safety profile.” This from Christine Cassiano, a company spokeswoman. “We’ve never had a report of chronic and persistent condition. Botox has been used in millions of people, so we feel very strongly about it.”

The most compelling portion of Allergan’s statement to V.F. is the “never” part, largely because it’s not quite true, V.F. has learned. In July 1999, in Yorba Linda, California, a registered nurse named Debbie Sulzle had her “nasolabial folds”—creases near her nose—Botoxed. The next day, she says, “I woke up and couldn’t move my mouth, couldn’t blink my eyes, and my face was virtually paralyzed.” Within a week, Sulzle says, she complained to Allergan. “They told me that they’d never heard of it before—but that it was going to get worse before it got better [because] the effect of Botox intensifies before it wears off.” She detailed her symptoms in December 1999, filling out a Patient Experience Report provided by Allergan. In a letter written two years later, during which time Sulzle says she was often bedridden, Allergan claimed that, because the F.D.A. had not specifically approved her treatment, “we are unable to provide data on the safety of this particular use.” Noting that “adverse effects following Botox injections are transient,” Allergan said, “We are very interested in following your condition.” Nearly four years after the treatment, Sulzle says, she’s still recovering, not nearly back to her pre-Botox condition, which was “as healthy as a horse.”

In December 2002, Karen Hicks received a Botox migraine treatment in Saint Petersburg, Florida, where she runs a salon called the Hair Hospital. About 10 days after the treatment, Hicks says, “I could not stand up, and I spent the next five weeks in bed. For about a week I thought it was the flu, but I didn’t run a fever or have nausea. I had extreme fatigue and pain in the neck and shoulder, which eventually traveled down my back.” In January, she says, Allergan put her in touch with a physician “who basically tried to convince me that I had lupus or M.S. or some terrible disease.” Hicks’s physician, Hisham Hanai, confirms her symptoms and says a full workup revealed no such diseases. The symptoms lasted two months, Hicks says, noting, “I’m still not back to complete normalcy.” Hicks complained to Allergan five days before Medavoy filed suit. Two weeks after that, Allergan sent Hicks a Patient Experience Report. Asked to explain the complaints by Sulzle and Hicks, Allergan’s Cassiano says, “We’re aware of both of those instances,” and adds that both were “ruled out by physicians. There was no link between their symptoms and Botox.” (While noting that Hicks’s most acute symptoms abated after a few weeks, Hanai says he was never contacted by Allergan.)

Clinical trials for three of Botox’s numerous off-label uses, including migraine relief and sweat reduction, have entered the final phases in the F.D.A. approval process. The former may well be indicated by 2006. Allergan’s profits are increasing in step with demand. Lasting all of 10 minutes, the simplest 20-unit Botox session with Klein will run you, at minimum, $640. That is, if you could get an appointment, which you can’t. Assuming Klein doesn’t get a discount from Allergan—for whom he’s a consultant—he pays about $4 per unit, meaning he makes a hefty profit.

Though Klein is hardly the only derm in town using Botox to treat migraines, his subspecialty gives some colleagues pause. “There are no guidelines for this,” says Dr. Harold Lancer, who may be Hollywood’s second-biggest derm, and who treated Medavoy after Klein did. “We usually do not see patients for migraine headaches. A patient doesn’t come into my office and say, ‘Listen, Dr. Lancer, I want you to treat my migraine headaches.’ That’s never happened. Theoretically, if it did happen, I would send him to a neurologist.” Though he won’t comment on Klein, Lancer does offer elliptical thoughts about his kind: “It’s a matter of pushing the envelope of safety. I don’t think I ever had a God complex, and if I did, I outgrew it a long time ago. That’s the way it is.”

“I think it’s fine for a dermatologist to treat migraines or anything else, as long as he’s trained,” says the founding father of Botox migraine therapy, Dr. William Binder, a plastic surgeon practicing in Beverly Hills, where he taught Klein to Botox. “I’ve done so much research and work in the area of migraines,” Klein said during his brief interview with V.F. “I’m an academic, and I’ve been studying this for years. It’s not as if I just said one day, ‘Hey, I think I’ll start treating migraines.’ Quite the opposite. I learned by clinical experience.”

The Arnold Klein case aside, the only thing everyone agrees on is that too many doctors with too much verve are dosing too many patients. Because any licensed prescriber can buy Botox, gynecologists, even podiatrists, are cashing in on a largely cosmetic procedure that’s yet to save a single life. Manhattan’s Dr. Roth says, “One patient told me her gynecologist called to tell her her Pap smear was fine, and, by the way, had she ever considered doing Botox?” Recently, Hollywood’s Dr. Paul Nassif gained a measure of fame by administering the drug at Botox parties at the Palms Casino Resort in Las Vegas, where “patients” snacked and mingled while pressing gauze to their bloodied foreheads. “They’re called Botox education seminars,” Nassif says, correcting the record. “Now I’m backing off from doing them because … I don’t know. Maybe it’s just not the best thing to do.”

In the meantime, the Klein-Medavoy imbroglio gets messier by the day, especially considering that all its parties are friends. Or were. “They’re having me followed,” Medavoy says. “In Beverly Hills. There’s a parking service right between Rodeo and Beverly Drive, behind Frédéric Fekkai, Giorgio Armani, and Ralph Lauren.” While she shopped one recent afternoon, two parking attendants noticed a man hiding in the bushes across the street, aiming a long telephoto lens. “What are you doing?” one of the attendants asked the man. “Just doing my job,” the man replied, according to both attendants. When Medavoy got into her car and drove off, the attendants say, three cars with tinted windows screeched after hers.

Asked if he or anyone associated with Klein had hired men to tail Medavoy, Weitzman says, “People have been following her? O.K., well … ” He laughs, throws his arms in the air, and says, “I suppose anything’s possible.” Either way, her shopping fuels Weitzman’s central thesis that “she’s out there all the time, rockin’ and rollin’ with the Stones and Bill Clinton.” He’s referring to a recent benefit concert attended by Medavoy and the ex-president, but he also refers to the Disneyland trip, wondering whether those teacups might be the source of her illness. “She appears to be cured by now. You and I should mend the way she’s mending.” He smiles. “She’s one of the more beautiful women around, and has as much energy as anybody I’ve ever met.”

“Mister Charm,” Irena Medavoy calls Weitzman, but not in a good way. She and his wife, Margaret, no longer speak. When Weitzman ran into Medavoy at the Stones concert, he hugged her and said, more or less, “I hope you won’t take this personally.”

By the time this case goes to trial—if it goes to trial—Botox may be facing stiff competition. On February 28 an F.D.A. advisory panel recommended the approval of Artecoll, a collagen-and-plastic-based drug said to reduce wrinkles permanently. “The data is pretty convincing,” said one of the panel members shortly before one of his colleagues stressed that 16 percent of the drug’s users may experience an “adverse event,” such as facial lumpiness. If all goes according to plan, Artecoll could hit Hollywood in time for Christmas.

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